San Francisco Bay Area Chapter In Person Event: Quality and Regulatory Summit: Navigating FDA Standards, Quality Systems & Inspection Readiness Across Medical Devices and Biopharmaceuticals

Maria Baker

Business Development Manager, UL Solutions

Maria Baker, is a Business Development Manager at UL Solutions with global leadership responsibilities. She contributes to the public health and safety mission by helping innovators bring cutting-edge medical technologies to market. Maria specializes in developing efficient global regulatory strategies, including support for the FDA ASCA program.

Maria holds a Bachelor of Science in Electrical Engineering from Cleveland State University and is an advocate of STEM education and leadership development. She remains dedicated to improving public health and safety by partnering with manufacturers, policymakers, and regulators to bring next-generation medical technology to market.

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Utpal Banik

Lead Auditor, TÜV Rheinland of North America Inc.

Utpal Banik, PhD, is an experienced Quality and Regulatory professional with 20+ years of experience in the Medical Device industry, with a strong commitment to advancing quality, safety, compliance, and patient well-being. He brings extensive expertise in Quality Management Systems, Regulatory Compliance, Risk Management, Medical Device Software, Cybersecurity, and Post-Market Surveillance.

His areas of expertise include FDA 21 CFR 820, EU MDR/IVDR (2017/745; 2017/746), ISO 13485, ISO 14971, IEC 62304, MDSAP, Design Controls, Computerized System Validation, SaMD, PCCP, CAPA/NCR/SCAR, Supplier Quality, Manufacturing Process Validation, Design Transfer, Vigilance System and Audits. 

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Clarissa Benfield

Global Business Director, Intertek ETL

Clarissa is the Global Director and Business Leader for Medical, Laboratory, and Life Safety &
Security at Intertek. With nearly 20 years of experience in the Assurance, Testing, Inspection,
and Certification (ATIC) industry, Clarissa has built her career helping organizations navigate
complex regulatory, quality, and safety requirements while accelerating innovation and market
access. Dedicated to Intertek's mission of bringing quality, safety, and sustainability to life,
Clarissa leads global teams that support manufacturers across the medical, laboratory, and life
safety sectors. She works closely with companies developing cutting-edge technologies and life-
changing products, helping them meet evolving standards, demonstrate compliance, and
deliver trusted solutions to customers worldwide. She is passionate about fostering
collaboration across the healthcare and life safety ecosystem and enabling the successful
commercialization of technologies that improve lives, enhance safety, and advance public well-
being.

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Eric Franca

Director of Conformity Assessment Program, FDA

Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nanomaterials for developing more effective neural electrodes. He began his professional career as a lead reviewer of medical devices at the Food and Drug Administration. He subsequently moved into a policy analyst position managing the content and publication of guidances, orders, and regulations related to medical device review and CDRH policies. He currently serves as Director of the Conformity Assessment Program in his role as an Assistant Director in CDRH’s Division of Standards and Conformity Assessment. Concurrent with his work as a regulator within the FDA, Dr. Franca has participated in standards development, serving in leadership positions within the US National Committee to the IEC and as an US technical expert on several standard development committees.

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Jon Gawlak

Technical Manager/Senior Auditor, SGS North America

Over 35 years of Quality and Project Management Experience with over 29 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry

Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management

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Portia Peng

Sr. Director, Global Quality Systems, Waters Biosciences (previously BD Biosciences)

Portia Peng is a senior quality and regulatory compliance leader with extensive experience across the medical device, IVD, and healthcare industries. She has held positions of increasing responsibility at Baxter Healthcare, Abbott Laboratories, Eli Lilly, Philips Healthcare, BD, and Waters Corporation, where she has led global quality management systems, regulatory compliance, and inspection readiness programs. Her areas of expertise include ISO 13485, FDA QMSR, EU IVDR, MDSAP, risk management, and product lifecycle quality.

Outside of her professional responsibilities, Portia enjoys cooking, practicing yoga, flying, traveling, hiking, and other outdoor activities that foster continuous learning, resilience, and personal growth.

: portia-peng-73207011

Sruti Lahkar

Senior Quality Lead, Genentech (Roche)

Sruti Lahkar is a quality and design assurance leader with more than 10 years of experience across the medical device and pharmaceutical industries, with expertise in SaMD, AI/ML, and digital health. She currently serves as Senior Quality Lead at Genentech (Roche), where she supports quality frameworks for investigational medical devices and software.

Her experience spans the quality management system (QMS) lifecycle, including design controls, risk management, supplier quality, CAPA, complaint handling, and audit readiness. She also serves as a member of the AAMI TIR 115 Working Group and holds an MS in Biomedical Engineering from the University of Southern California.

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Mary Hole

Branch Chief, San Jose Resident Post , U.S. Food and Drug Administration (FDA)

Mary Hole is a Branch Chief with the U.S. Food and Drug Administration (FDA), where she oversees the San Jose Resident Post and leads a team of medical device investigators based in the San Jose Resident Post and Alameda District Office.

Before joining the FDA in 2010, Mary spent more than 20 years in the pharmaceutical industry, first as a chemist and later as a Regulatory Compliance Manager. She also established a consulting business focused primarily on Drug Enforcement Administration (DEA) regulatory compliance for controlled substances. At the FDA, Mary began as an Investigator conducting medical device inspections, became a Supervisor in 2016, and was appointed Branch Chief in 2023. The San Jose Resident Post includes investigators across multiple commodities, including Foods, Pharma, BIMO, Medical Devices, and Import Operations. Mary holds a bachelor’s degree in biology from San Jose State University and an MBA.

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Binh Nguyen

Founder and President, Wynngate Corporation

Dr. Binh Nguyen is the founder and president of Wynngate Corporation, a GXP consulting firm. He retired from the FDA in March 2023 after more than 20 years specializing in bio/pharmaceutical training, compliance, management, and inspectional audits. During his FDA career, he served in roles including Level III certified pharmaceutical inspectorate, Level II drug auditor, Drug Branch Chief, and Director Regulatory Review Officer for biotech, sterile injectables, combination products, and other dosage forms.

Dr. Nguyen also practiced clinical hospital pharmacy for more than 23 years and served as a council member in sterile compounding pharmacy for the Board of Pharmacy Specialties. He holds a doctorate in pharmacy and a master’s degree in regulatory science. He is also the founder and developer of ieQip (intelligent electronic Quality Inspection Platform), an AI-based global inspection software, and currently serves as a course builder and instructor for the Parenteral Drug Association (PDA) and the University of Southern California’s regulatory program.

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June-Mei Han

Chief, Drug and Medical Device Compliance and Enforcement Section, California Department of Public Health (CDPH)

June-Mei Han is the Chief of the Drug and Medical Device Compliance and Enforcement Section at the California Department of Public Health (CDPH) Food and Drug Branch. She has 24 years of experience with the branch, beginning her career in its food safety program. For the past 19 years, she has focused on pharmaceutical and medical device regulation and enforcement. June holds a degree in Molecular and Cell Biology from the University of California, Berkeley.

Stacey Masters

Drug and Medical Device Inspector, California Department of Public Health (CDPH), Food and Drug Branch

Stacey Masters has 19 years of experience with the California Department of Public Health (CDPH) Food and Drug Branch, with a focus on regulatory work across the drug, medical device, and cosmetic industries. She holds a Bachelor of Science in Nutrition from the University of California, Davis, and a Master of Public Health from Loma Linda University.

Kok-Seong Lim

Founder and Principal, Eight Crest Strategies

Kok Seong Lim, BPharm, PhD, RAC, is the Founder and Principal of Eight Crest Strategies. He brings more than 20 years of experience in biologics research and development, with leadership roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific. Throughout his career, he has advanced more than 15 gene therapy, cell therapy, and gene-editing programs spanning AAV, mRNA and guide RNA, lipid nanoparticles, Cas enzymes, and oligonucleotides.

His experience includes building GMP manufacturing and analytical infrastructure, developing phase-appropriate control strategies, and contributing CMC content to regulatory submissions and health authority interactions in the U.S. and Europe. He serves on the USP Biologics—Cell and Gene Therapy Expert Committee, contributes to ISO/TC 276, and serves as Chair of the RAPS San Francisco Bay Area Chapter. He holds a PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.

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Maurizio Franzini

Senior Director, RA CMC, Small Molecules, Gilead Sciences

Maurizio Franzini is a Regulatory CMC professional with multi-year experience supporting synthetic molecules across a broad range of therapeutic indications. He is a strategic planner and contributors to eCTD quality sections in marketing applications, INDs/IMPDs and related amendments, post-approval changes, and annual reports, covering oral and subcutaneous dosage forms as single agents and fixed-dose combinations across multiple regions. Maurizio contributes to strategy and content in response to agency requests for information and letters of non-acceptance and supports phase-appropriate manufacturing control strategies that safeguard patient safety while meeting regulatory expectations. He’s currently the proud people manager of a fantastic RA CMC team, focusing on their individual development and empowerment. Earlier in his career, Maurizio spent over a decade as a synthetic organic and medicinal chemist in drug discovery, from lead validation to development candidates. His work is reflected in a record of publications and patents

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Dara Wambach, MA

Executive Director of Regulatory Affairs, Mirum Pharmaceuticals

Dara Wambach, MA, is Executive Director of Regulatory Affairs at Mirum Pharmaceuticals and a regulatory and R&D leader with more than 20 years of experience advancing therapies from early development through commercialization. Her experience includes regulatory leadership roles across small and mid-sized Bay Area biotechnology companies, including more than a decade at Gilead where she led the U.S. regulatory submission and FDA review for the first HIV pre-exposure prophylaxis (PrEP) indication for Truvada.

Dara has contributed to pediatric development programs in HIV, sickle cell disease, and narcolepsy, as well as programs addressing pulmonary and liver diseases. At Janssen Global Public Health R&D, she developed and led Johnson & Johnson’s two-year R&D Fellowship Program with the Institute of Tropical Medicine Antwerp for scientist-physicians from Africa. She is also a member of the RAPS San Francisco Bay Area Chapter Leadership Team and serves as Chair of the Sponsorship Committee.

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Ankita Joshi

Regulatory Affairs Specialist, ReCor Medical

Ankita Joshi, MS, is a Regulatory Affairs Specialist at ReCor Medical with more than four years of experience navigating the medical device industry. With a background in biomedical engineering and healthcare management, she supports regulatory strategy and compliance with U.S. FDA and EU MDR requirements.

In addition to her role at ReCor Medical, Ankita serves as the Device Programming Committee Leader for the RAPS San Francisco Bay Area Chapter. She leads the development and organization of regional events for Silicon Valley’s regulatory community and is committed to fostering collaboration on emerging industry trends.

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